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news.Zonagen has received approval from the investigational review board to begin its phase III study of Androxal, a once-a-day oral therapy for the treatment of testosterone deficiency resulting from a condition known as secondary hypogonadism.
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The 200 patient study is designed to assess both the safety of Androxal and its efficacy in restoring normal pituitary and testicular function in men that are hypogonadal due to secondary hypogonadism.
Secondary hypogonadism is a failure of appropriate signaling from the pituitary to the testes. The condition is most common in aging males but can result from a variety of causes, including the use of androgens.
The double-blind study will test two doses of Androxal versus placebo and will include an open-label arm of the commercially available drug Androgel.
The dosing phase of the trial has been extended to 24 weeks in order to satisfy an FDA request regarding the safety of restoring normal testicular function as compared to placebo or the currently approved testosterone replacement therapies.
The company believes that at least two additional phase III pivotal studies beyond the currently planned study will be required before an NDA can be submitted.